Study Of Lapatinib In Patients With Relapsed Or Refractory Inflammatory Breast Cancer

Conditions

• Neoplasms, Breast

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• lapatinib — DRUG
  Tyrosine kinase inhibitor administered daily at 1500 mg/kg

Study Details

This study was designed to determine how effective and safe a new investigational drug, lapatinib, is in treating patients with treatment refractory or relapsed inflammatory breast cancer. Tumor tissue collected pre-treatment and at Day 28 will be examined for biologic activity by IHC (immunohistochemistry). Treatment will consist of daily oral therapy with lapatinib. A patient may continue treatment as long as they are receiving benefit. Blood samples for hematology and chemistry panels, MUGA/ECHO (multigated acquisition/echocardiogram) exams and physical exams will be performed throughout the study to monitor safety.

Key Dates

Start date

Mar 31, 2005

Status verified

May 2015

Primary completion

Sep 30, 2007

Completion

May 31, 2010

Study Design

Enrollment

126 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Lapatinib
  Single arm study of lapatinib with no comparator arm.

Primary Outcome Measure

Objective Response rate (complete response plus partial response) [ Time Frame: Week 84 ]

Locations (8)

Find similar trials in Miami, FL